FESOTERODINE CINFA 4 mg PROLONGED-RELEASE TABLETS

Introduction

Package Leaflet: Information for the User

Fesoterodina Cinfa 4 mg prolonged-release tablets EFG

fesoterodine fumarate

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What is Fesoterodina Cinfa and what is it used for
2. What you need to know before you take Fesoterodina Cinfa
3. How to take Fesoterodina Cinfa
4. Possible side effects
5. Storage of Fesoterodina Cinfa
6. Contents of the pack and other information

1. What is Fesoterodina Cinfa and what is it used for

Fesoterodina Cinfa contains the active substance fesoterodine fumarate and is a treatment called an antimuscarinic, which reduces the activity of the overactive bladder and is used in adults to treat symptoms.

Fesoterodina Cinfa treats the symptoms of an overactive bladder, such as:

• being unable to control when to urinate (urge incontinence)
• a sudden need to urinate (urgency)
• having to urinate more often than usual (increased frequency of urination)

2. What you need to know before you take Fesoterodina Cinfa

Do not take Fesoterodina Cinfa:

Warnings and precautions

Talk to your doctor or pharmacist before you start taking fesoterodine.

Fesoterodine may not always be suitable for you. Inform your doctor before taking fesoterodine in any of the following cases:

Heart problems: Inform your doctor if you have any of the following conditions:

• a heart condition called QT interval prolongation or if you are taking any medicine that is known to have this effect
• a slow heart rate (bradycardia)
• a heart condition such as myocardial ischemia (reduced blood flow to the heart), irregular heartbeats, or heart failure
• low potassium levels in the blood (hypokalemia)

Children and adolescents

Do not give this medicine to children and adolescents under 18 years of age because it has not been established whether it works and is safe for them.

Other medicines and Fesoterodina Cinfa

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. Your doctor will tell you whether you can use fesoterodine with other medicines.

Please inform your doctor if you are taking any of the medicines listed below. Taking these medicines at the same time as fesoterodine may cause side effects such as dry mouth, constipation, difficulty fully emptying the urinary bladder, or more severe or frequent drowsiness than usual.

• Medicines that contain the active substance amantadine (used to treat Parkinson's disease)
• Certain medicines used to increase gastrointestinal motility or to relieve stomach cramps or spasms, such as medicines that contain metoclopramide
• Certain medicines used to treat psychiatric disorders, such as antidepressants and neuroleptics

Please also inform your doctor if you are taking any of the following medicines:

• medicines that contain any of the following active substances that may increase the metabolism of fesoterodine and thus decrease its effect: St. John's Wort (hypericum, herbal medicine), rifampicin (used to treat bacterial infections), carbamazepine, phenytoin, and phenobarbital (used, among others, to treat epilepsy)
• medicines that contain any of the following active substances that may increase fesoterodine levels in the blood: itraconazole or ketoconazole (used to treat fungal infections), ritonavir, atazanavir, indinavir, saquinavir, or nelfinavir (antiviral medicines used to treat HIV infection), clarithromycin or telithromycin (used to treat bacterial infections), nefazodone (used to treat depression), fluoxetine or paroxetine (used to treat depression or anxiety), bupropion (used to quit smoking or treat depression), quinidine (used to treat arrhythmias), and cinacalcet (used to treat hyperparathyroidism)
• medicines that contain the active substance methadone (used to treat severe pain and drug dependence)

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

You should not take fesoterodine if you are pregnant, as the effects of fesoterodine on pregnancy and the newborn are unknown.

It is unknown whether fesoterodine is excreted in breast milk; therefore, do not breastfeed during treatment with fesoterodine.

Driving and using machines

Fesoterodine may cause blurred vision, dizziness, and drowsiness. If you experience any of these effects, do not drive or operate tools or machines.

Fesoterodina Cinfa contains lactose

If your doctor has told you that you have an intolerance to some sugars, consult with them before taking this medicine.

Fesoterodina Cinfa contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; this is, essentially, "sodium-free".

3. How to take Fesoterodina Cinfa

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist again.

The recommended initial dose of fesoterodine is one 4 mg tablet per day. Depending on how you respond to the medicine, your doctor may prescribe a higher dose; one 8 mg tablet per day.

Swallow the tablet whole with a glass of water. Do not chew the tablet. Fesoterodina Cinfa can be taken with or without food.

To help you remember to take your medicine, it may be more convenient to take it at the same time every day.

If you take more Fesoterodina Cinfa than you should

If you have taken more tablets than you should or if someone else has taken your tablets, contact your doctor or hospital immediately. Show them the pack of tablets.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Fesoterodina Cinfa

If you have forgotten to take a tablet, take it as soon as you remember, but do not take more than one tablet in a day. Do not take a double dose to make up for forgotten doses.

If you stop taking Fesoterodina Cinfa

Do not stop taking fesoterodine without talking to your doctor first, as the symptoms of an overactive bladder may return or worsen when you stop taking fesoterodine.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Some side effects can be serious

Rarely, severe allergic reactions, including angioedema, may occur. You should stop taking fesoterodine and contact your doctor immediately if you develop swelling in the face, mouth, or throat.

Other side effects

Very common(may affect more than 1 in 10 people):

You may notice dry mouth. This effect is usually mild or moderate. This may increase the risk of tooth decay. Therefore, you should brush your teeth regularly, twice a day, and visit a dentist if you have any doubts.

Common(may affect up to 1 in 10 people)

• dry eyes
• constipation
• digestive disorders (dyspepsia)
• pain or discomfort when urinating (dysuria)
• dizziness
• headache
• stomach pain
• diarrhea
• nausea
• difficulty sleeping (insomnia)
• dry throat

Uncommon(may affect up to 1 in 100 people)

• urinary tract infection
• drowsiness
• difficulty tasting (dysgeusia)
• vertigo
• rash
• dry skin
• itching
• stomach discomfort
• gas (flatulence)
• difficulty fully emptying the urinary bladder (urinary retention)
• delayed urination (difficulty starting urination)
• extreme fatigue (fatigue)
• increased heart rate (tachycardia)
• palpitations
• liver problems
• cough
• dry nose
• sore throat
• acid reflux
• blurred vision

Rare(may affect up to 1 in 1,000 people)

• hives
• confusion

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Spanish Pharmacovigilance System for Human Use: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Fesoterodina Cinfa

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton and blister after EXP. The expiry date is the last day of the month stated.

Do not store above 30°C.

Store in the original package to protect from moisture.

Medicines should not be disposed of via wastewater or household waste. Return any unused medicine to a pharmacy for proper disposal. This will help protect the environment.

6. Contents of the pack and other information

Composition of Fesoterodina Cinfa

• The active substance is fesoterodine fumarate. Each prolonged-release tablet contains 4 mg of fesoterodine fumarate, equivalent to 3.1 mg of fesoterodine.
• The other ingredients are:

Core of the tablet: dibehenate of glycerol, hypromellose, talc, and lactose monohydrate (see section 2 "Fesoterodina Cinfa contains lactose and sodium")/microcrystalline cellulose.

Coating: polyvinyl alcohol, talc, titanium dioxide (E-171), glycerol monocaprylate (Type I), sodium lauryl sulfate, and aluminum lake crimson (E-132).

Appearance of the product and pack contents

Prolonged-release tablets are light blue, oval, biconvex, film-coated, and marked with the number "4" on one side.

Fesoterodina Cinfa is available in OPA/Alu/PVC-Alu blisters in packs containing 10, 14, 20, 28, 30, 40, 42, 50, 56, 60, 70, 80, 84, 90, 98, and 100 prolonged-release tablets.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) – Spain

Manufacturer

Rontis Hellas Medical and Pharmaceutical Products S.A.

Larissa Industrial Area, P.O. Box 3012,

Larissa, 41 500, Greece

or

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) – Spain

Date of last revision of this leaflet: 04/2021

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/

You can access detailed and updated information about this medicine by scanning the QR code included in the leaflet and packaging with your mobile phone (smartphone). You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/86136/P_86136.html

QR code to: https://cima.aemps.es/cima/dochtml/p/86136/P_86136.html